Serum-derived Bovine Immunoglobulin Effect on Mucositis

Mucositis Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Pilot Study of Serum-Derived Bovine Immunoglobulin/Protein Isolate to Manage Mucositis in Patients Undergoing Treatment for Head, Neck, or Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04239261
• Other study ID #: HNL-MUCO
• Status: Terminated
• Phase: Phase 2
• Start date: January 17, 2020
• Est. completion date: January 24, 2023

Study information

• Verified date: January 2023
• Source: MercyOne Des Moines Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this cancer control clinical research study is to evaluate whether nutritional therapy with Serum-derived bovine immunoglobulin/protein isolate (SBI) might reduce mucositis (a condition caused by cancer treatment involving mouth sores, pain and/or bleeding that may cause difficulty eating), improve nutritional status and lessen the symptoms associated with chemo-radiation therapy which may result in quality of life (QOL) improvements during the prescribed treatment for cancer therapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Informed consent obtained and signed

2. Male or female at least 18 years of age

3. Diagnosed with head, neck, or lung cancer and scheduled to undergo combined chemo-radiation therapy

4. Diagnosed with head, neck, or lung cancer with disease stage within the criteria described in 4.0 Staging Criteria

5. Not experiencing diarrhea during the 5 days preceding enrollment, as defined by having less than two unformed bowel movements per day or loose (mushy) or watery stools in the 5 days preceding enrollment.

6. Not currently taking anti-diarrheal medications (prescription or over the counter).

7. Agrees and is able to take the investigational products or placebo starting from the day of enrollment (approximately 7-14 days prior to beginning chemo-radiation therapy) through 6-7 weeks of chemo-radiation therapy (for a total of 8-9 weeks).

Exclusion Criteria:

1. History of uncontrolled diarrhea during screening.

2. History of Irritable Bowel Syndrome with Diarrhea with a normal pattern of more than three bowel movements in a 24 hour period.

3. History of inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis.

4. History of active infectious diarrhea and receiving therapy within 10 days of the first dose of study drug or placebo.

5. Known allergy or intolerance to beef or soy or any ingredient used in the product

6. History of concurrent intensive chemotherapy within 10 days of the first scheduled dose of study drug or placebo.

7. Gastrointestinal surgery or bowel resection that could affect study product absorption (this does not include cholecystectomy or appendectomy).

8. Unable to comply with the protocol requirements.

9. Any condition that in the opinion of the Investigator might interfere with the study objective.

10. Women who are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Mucositis

Intervention

Dietary Supplement:
• SBI
Serum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily
• Placebo
Hydrolyzed gelatin 10.0 g once daily

Locations

Country	Name	City	State
United States	MercyOne Des Moines Medical Center	Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
MercyOne Des Moines Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Oral Mucositis during ChemoRadiation Treatment	CTCAE version 5 will be used to determine adverse event grade of mucositis, if applicable	Baseline and Up to approximately 90 days after randomization
Secondary	Development of Dysphagia during ChemoRadiation Treatment	CTCAE version 5 will be used to determine advent grade of dysphagia, if applicable	Baseline and Up to approximately 90 days after randomization
Secondary	Change in Bowel Movements	Stool Diary Card will be completed by patient to document consistency, ease and completeness	Baseline and Up to approximately 90 days after randomization